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This is a phase 3, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate the efficacy and safety of 50 units (U) of QM1114-DP for the treatment of moderate to severe GL in male and female subjects of Chinese origin. The study has been designed to test the superiority of QM1114-DP compared to placebo, and the non-inferior efficacy of QM1114-DP compared to onabotulinumtoxinA (BOTOX®), in improving the appearance of moderate to severe GL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Single injection with QM1114-DP in glabellar lines |
|
| Active-Controlled Group | Active Comparator | Single injection with BOTOX® in glabellar lines |
|
| Placebo-Controlled Group | Placebo Comparator | Single injection with placebo in glabellar lines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QM1114-DP | Biological | Intramuscular injection |
| |
| OnabotulinumtoxinA |
| Measure | Description | Time Frame |
|---|---|---|
| The composite responder rate will be evaluated at Month 1 using the GL-ILA and the GL-SLA at maximum frown. | A composite responder is defined as a subject who achieves a score of 0 or 1 in GL severity and at least 2 grades improvement from baseline on both the GL-ILA and GLSLA scales concurrently. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Wu | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Second Provincial General Hospital | Guangzhou | Guangdong | 510317 | China | ||
| Xiangya 3rd Hospital |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Biological |
Intramuscular injection |
|
| Placebo | Biological | Intramuscular injection |
|
| Changsha |
| Hunan |
| China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | China |
| Beijing Tongren Hospital, CMU | Beijing | 100730 | China |
| Peking University First Hospital | Beijing | China |
| Tianjin University General Hospital | Tianjin | China |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |